Trial · NCT01170117
Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
NCT01170117, Not applicable, Completed, New York State Psychiatric Institute; results first posted 2017-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa. Trials, record NCT01170117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01170117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
- NCT number
- NCT01170117
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 152 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Anorexia Nervosa
- Interventions
- Olanzapine, Placebo
- First posted
- 2010-07-27
- Last updated
- 2018-06-29
- Results first posted
- 2017-08-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Weight Change | Weekly during 16-week trial and twice during 8 weeks follow-up | Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo |
| Primary | Psychological Change | Weekly during 16-week intervention and twice during 8-week follow-up | Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Weight Change | Weekly during 16-week trial and twice during 8 weeks follow-up | Patients assigned to receive placebo or olanzapine for 16 weeks. | kg/m^2 per month | MEAN |
| PRIMARY | Psychological Change | Weekly during 16-week intervention and twice during 8-week follow-up | YBOCs score units per month | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Weight Change | Placebo | 0.095 | Standard Error 0.053 | kg/m^2 per month | |
| Rate of Weight Change | Olanzapine | 0.260 | Standard Error 0.051 | kg/m^2 per month | |
| Psychological Change | Placebo | 0.762 | Standard Deviation 0.375 | YBOCs score units per month | |
| Psychological Change | Olanzapine | 0.800 | Standard Deviation 0.350 | YBOCs score units per month |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 77 | |
| Overall Study | STARTED | Olanzapine | 75 | |
| Overall Study | COMPLETED | Placebo | 47 | |
| Overall Study | COMPLETED | Olanzapine | 55 | |
| Overall Study | NOT COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Olanzapine | 20 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild undulating movement in his posterior tongue on the Abnormal Involuntary Movement Scale | Musculoskeletal and connective tissue disorders | Placebo | 0 | 77 | 0 |
| other | Mild undulating movement in his posterior tongue on the Abnormal Involuntary Movement Scale | Musculoskeletal and connective tissue disorders | Olanzapine | 1 | 75 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 0 | 77 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Olanzapine | 1 | 75 | 1 |
| serious | Patient hospitalized in eating disorder center to pursue higher level of care. | Psychiatric disorders | Placebo | 7 | 77 | 7 |
| serious | Patient hospitalized in eating disorder center to pursue higher level of care. | Psychiatric disorders | Olanzapine | 11 | 75 | 11 |
| serious | Overdose | Injury, poisoning and procedural complications | Placebo | 0 | 77 | 0 |
| serious | Overdose | Injury, poisoning and procedural complications | Olanzapine | 2 | 75 | 2 |
| serious | Abnormal EKG | Cardiac disorders | Placebo | 1 | 77 | 1 |
| serious | Abnormal EKG | Cardiac disorders | Olanzapine | 1 | 75 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 77 |
| Total, all-cause mortality | Olanzapine | 0 | 75 |
| Total, other adverse events | Placebo | 0 | 77 |
| Total, other adverse events | Olanzapine | 2 | 75 |
| Total, serious adverse events | Placebo | 13 | 77 |
| Total, serious adverse events | Olanzapine | 16 | 75 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH085921 | Olanzapine Versus Placebo in Outpatients with Anorexia Nervosa | ATTIA, EVELYN | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE OF MENTAL HEALTH | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olanzapine vs Placebo: deaths from any cause | Trial comparisons |
| Olanzapine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01170117
GET https://conductscience.org/api/trials/v1/NCT01170117/registered